Job Description

Director, Analytical Team Leader

• Lead the delivery of all analytical activities to take a portfolio of new respiratory products to clinical studies and commercialization.
• As a portfolio lead, support the planning and execution of experiments to generate scientific understanding in development of analytical methods, formulations, and processes.
• Ensure the smooth transfer of project analytical methodologies to commercial manufacturing facility.
• Lead the review and approval of data, interpretation of results and reporting of experimental outcomes to project development teams.
• Ensure that analytical activities carried out within the team with potential impact on quality of clinical supplies or product approval are delivered in accordance with cGMP requirements.
• As a member of the analytical leadership team, take shared accountability for driving high standards of scientific excellence, cGMP compliance and safety within the Analytical function. Contribute to strategic business development and management of resources to deliver the project portfolio on time and within budget.
• Lead scientific input to troubleshooting and investigations.
• Review and approve documentation (e.g. protocols, reports, procedures, specifications) as required.
• Lead the delivery of analytical input to investigational and commercial drug product regulatory filings.
• Take responsibility for performance management and professional development of staff within the team.
• Lead the improvement of departmental capabilities, e.g. by implementation of new technologies.
• Adhere to all applicable policies and procedures, including those relating to EHS, GMP, GCP,
• Quality and Compliance, consistent with the role and any associated responsibilities, including people management where applicable.
• Shape formulation design and scale up strategies and overall project plans through input and leadership at matrix team technical discussions.
• Perform other duties as assigned consistent with the grade of the role.

• Has substantial experience of the application of analytical chemistry to product development (Respiratory / Inhalation products), including practical experience of modern laboratory techniques (e.g. drug product testing, API characterization).
• Has substantial experience in the management of analytical activities to achieve project deliverables.
• Has substantial experience in performance management and personal development of others.
• Has substantial experience in authoring GMP documentation and preparing regulatory submissions.
• Has substantial experience of the challenges involved in the validation and transfer of complex analytical methods to commercial facilities.
• Able to lead the interpretation of complex data to solve product development issues.
• Able to proactively identify and address barriers to collaborative working with internal and external partners.
• Able to work autonomously to deliver multiple tasks of high complexity across a portfolio of products, working with team leaders to plan work across multiple teams to consistently achieve output of high-quality results in a timely manner.
• Has a good understanding of cGMP requirements for analytical work in support of clinical studies and product registration.
• Has substantial experience of the specific challenges involved in the development, approval and commercialization of inhaled products, including dry powder inhalers.
• Has a good understanding of material properties that impact dry powder inhaler performance in vitro and in vivo.
• Familiar with the use of project management tools, e.g. Microsoft Project.
• Effective verbal and written communication skills.
• Occasional business travel as required.

PharmiWeb.jobs